Farkas Klaudia, Rutka Mariann, Golovics Petra A, Végh Zsuzsanna, Lovász Barbara D, Nyári Tibor, Gecse Krisztina B, Kolar Martin, Bortlik Martin, Duricova Dana, Machkova Nadezda, Hruba Veronika, Lukas Martin, Mitrova Katarina, Malickova Karin, Bálint Anita, Nagy Ferenc, Bor Renáta, Milassin Ágnes, Szepes Zoltán, Palatka Károly, Lakatos Péter L, Lukas Milan, Molnár Tamás
1 Department of Medicine, University of Szeged, Szeged, Hungary.
1 Department of Medicine, Semmelweis University, Budapest, Hungary.
J Crohns Colitis. 2016 Nov;10(11):1273-1278. doi: 10.1093/ecco-jcc/jjw085. Epub 2016 Apr 21.
CT-P13 is the first biosimilar to infliximab that has been approved for the same indications as its originator infliximab. No data are available on the effect of infliximab biosimilar on mucosal healing. The aim of this study was to evaluate the efficacy of CT-P13 induction therapy on mucosal healing in patients with ulcerative colitis [UC].
UC patients, who received CT-P13 therapy from its local introduction at three Hungarian and one Czech inflammatory bowel disease centres, were prospectively enrolled. Sigmoidoscopy was performed after the end of the induction therapy at week 14. Mucosal healing was defined as Mayo endoscopic subscore 0 or 1. Complete mucosal healing was defined as Mayo endoscopic subscore 0. Trough level of CT-P13 was measured at week 14.
Sixty-three UC patients who underwent CT-P13 induction therapy were enrolled in the study. Indication for the therapy was acute, severe flare up and chronic, refractory activity in 24 and 39 patients, respectively. Cumulative clinical response and steroid-free remission at week 14 were achieved in 82.5% and 47.6% of the patients, respectively. Sigmoidoscopy revealed steroid-free mucosal healing in 47.6% of the patients, and complete mucosal healing was present in 27%. Mayo endoscopic subscore decreased significantly at week 14 compared to baseline. Trough levels of infliximab correlated with mucosal healing.
This is, to our knowledge, the first study examining the efficacy of CT-P13 induction therapy on mucosal healing in UC. The results indicate that mucosal healing is achieved in two-thirds of UC patients by the end of the induction treatment with CT-P13.
CT-P13是首个获批与原研英夫利昔单抗具有相同适应症的英夫利昔单抗生物类似药。目前尚无关于英夫利昔单抗生物类似药对黏膜愈合影响的数据。本研究旨在评估CT-P13诱导疗法对溃疡性结肠炎（UC）患者黏膜愈合的疗效。
前瞻性纳入了在匈牙利的三个和捷克的一个炎症性肠病中心从当地引进CT-P13治疗后接受该治疗的UC患者。在诱导治疗第14周结束后进行乙状结肠镜检查。黏膜愈合定义为梅奥内镜亚评分为0或1。完全黏膜愈合定义为梅奥内镜亚评分为0。在第14周测量CT-P13的谷浓度。
63例接受CT-P13诱导治疗的UC患者纳入本研究。治疗适应症分别为24例急性重度发作和39例慢性难治性活动。第14周时分别有82.5%和47.6%的患者实现了累积临床缓解和无激素缓解。乙状结肠镜检查显示47.6%的患者实现了无激素黏膜愈合，27%的患者实现了完全黏膜愈合。与基线相比，第14周时梅奥内镜亚评分显著降低。英夫利昔单抗的谷浓度与黏膜愈合相关。
据我们所知，这是第一项研究CT-P13诱导疗法对UC患者黏膜愈合疗效的研究。结果表明，在CT-P13诱导治疗结束时，三分之二的UC患者实现了黏膜愈合。
